212 F.3d 1241 (Fed. Cir. 2000), 99-1365, Bayer AG and Bayer v Elan Pharm.

Docket Nº:99-1365
Citation:212 F.3d 1241
Case Date:May 12, 2000
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1241

212 F.3d 1241 (Fed. Cir. 2000)

BAYER AG and BAYER CORPORATION, Plaintiffs-Appellants,





United States Court of Appeals, Federal Circuit

May 12, 2000

Appealed from: United States District Court for the Northern District of Georgia Senior Judge William C. O'Kelly

Page 1242

[Copyrighted Material Omitted]

Page 1243

Rudolf E. Hutz, Connolly, Bove, Lodge & Hutz, of Wilmington, Delaware, argued for plaintiffs-appellants. With him on the brief were Jeffrey B. Bove, Mary W. Bourke, and William E. McShane.

Gary N. Frischling, Irell & Manella LLP, of Los Angeles, California, argued for defendants-appellees. With him on the

Page 1244

brief were Richard M. Birnholz, Flavio Rose, and Nicola J. Bird.

Before CLEVENGER, SCHALL, and BRYSON Circuit Judges.

SCHALL, Circuit Judge.

Bayer AG and Bayer Corporation (collectively, "Bayer") own United States Patent No. 5,264,446 (the "'446 patent"). The '446 patent claims a pharmaceutical composition that contains nifedipine crystals of a defined specific surface area ("SSA"). The patent also claims the composition's method of preparation and a method of treatment using the composition. Bayer sued Elan Pharmaceutical Research Corporation and Elan Corporation, PLC (collectively, "Elan") in the United States District Court for the Northern District of Georgia alleging infringement by Elan of the '446 patent. Bayer alleged infringement under 35 U.S.C. § 271(e)(2)(A)1 based on Elan's filing of an abbreviated new drug application ("ANDA") seeking approval by the Food and Drug Administration ("FDA") of a generic version of Bayer's ADALAT CC, Bayer's commercial embodiment of the pharmaceutical composition claimed in the '446 patent. The district court granted Elan's motion for summary judgment on both literal infringement and infringement under the doctrine of equivalents and entered judgment for Elan. See Bayer AG v. Elan Pharm. Research Corp., 64 F.Supp.2d 1295, 1304 (N.D. Ga. 1999). We affirm.


A. The ANDA Process

As this court has described before, the Hatch-Waxman Act (the "Act") amended the Federal Food, Drug, and Cosmetic Act, Pub. L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et. seq. (1994)) (the "FDCA"), as well as the patent laws. See Bristol-Myers Squibb Co. v. Royce Lab., Inc., 69 F.3d 1130, 1131-32, 36 USPQ2d 1641, 1642-43 (Fed. Cir. 1995); DuPont Merck Pharm. Co. v. Bristol-Myers Squibb Co., 62 F.3d 1397, 1399-1401, 35 USPQ2d 1718, 1720-21 (Fed. Cir. 1995). Under the FDCA, as amended by the Act, a pharmaceutical manufacturer submits an ANDA when seeking expedited FDA approval of a generic version of a drug previously approved by the FDA (a "listed drug"). See 21 U.S.C. § 355(j). An ANDA can be filed if the generic drug manufacturer's active ingredient is the "bioequivalent"2 of the listed drug. See 21 U.S.C. § 355(j)(2)(A)(iv). When submitting an ANDA, a manufacturer must certify one of four statements concerning the applicable listed drug: (i) the listed drug is not patented (a "Paragraph I certification"); (ii) the listed drug's patent has expired (a "Paragraph II certification"); (iii) the expiration date of the listed drug's patent (a "Paragraph III certification"); or (iv) the listed drug's patent "is invalid or . . . it will not be infringed by the manufacture, use, or sale of the new drug" covered by the ANDA (a "Paragraph IV certification"). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). If an ANDA is certified under Paragraph IV, the applicant must notify the patent's owner of the certification. See 21 U.S.C. § 355(j)(2)(B).

An ANDA certified under Paragraphs I or II is approved immediately after meeting

Page 1245

all applicable scientific and regulatory requirements. See 21 U.S.C. §§ 355(j)(5)(A), (B)(i). An ANDA certified under Paragraph III must, even after meeting all applicable scientific and regulatory requirements, wait for approval until the listed drug's patent expires. See 21 U.S.C. §§ 355(j)(5)(A), (B)(ii). An ANDA certified under Paragraph IV is approved immediately after meeting all applicable scientific and regulatory requirements unless the listed drug's patent owner brings suit for infringement under 35 U.S.C. § 271(e)(2)(A) within forty-five days of receiving the notice required under 21 U.S.C. § 355(j)(2)(B). See 21 U.S.C. § 355(j)(5)(B)(iii). If suit is brought, the FDA is required to suspend approval of the ANDA, and the FDA cannot approve the ANDA until the earliest of three dates: (i) the date of the court's decision that the listed drug's patent is either invalid or not infringed; (ii) the date the listed drug's patent expires, see 35 U.S.C. § 271(e)(4)(A), if the court finds the listed drug's patent infringed; or (iii) subject to modification by the court, the date that is thirty months from the date the owner of the listed drug's patent received notice of the filing of a Paragraph IV certification. See 21 U.S.C. § 355(j)(5)(B)(iii)(I)-(III).

The Act modified the patent laws to provide that "[i]t shall not be an act of infringement to make, use, or sell . . . a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." 35 U.S.C. § 271(e)(1). A Paragraph IV certification, however, is deemed to be an act of infringement "if the purpose of such a submission is to obtain approval under the [FDCA] to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such a patent." 35 U.S.C. § 271(e)(2)(A); see also Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1567, 42 USPQ2d 1257, 1261-62 (Fed. Cir. 1997). "If the court determines that the patent is not invalid and that infringement would occur, and that therefore the ANDA applicant's [P]aragraph IV certification is incorrect, the patent owner is entitled to an order that FDA approval of the ANDA containing the [P]aragraph IV certification not be effective until the patent expires." Royce Lab., 69 F.3d at 1135, 36 USPQ2d at 1646 (emphasis omitted).

B. The '446 patent

The application that matured into the '446 patent was filed on August 20, 1981; the '446 patent issued on November 23, 1993. The '446 patent relates to solid pharmaceutical compositions, such as tablets, that contain nifedipine crystals of a given SSA,3 combined with a solid diluent that is adapted for formation into tablets. Nifedipine is a compound that acts on the body's circulation--a coronary vasodilator--and is used to control such medical conditions as high blood pressure. The '446 patent attempts, through its claimed SSA for nifedipine crystals, to address the problem of poor solubility--absorption of nifedipine into the blood--while still maintaining a sustained presence of nifedipine in the blood, i.e., high bioavailability. The patent seeks to achieve its objective without using such disadvantageous means as large-sized tablets, which are hard to swallow, or liquid formulations, which are very expensive and require protection from light.

The '446 patent contains twelve independent claims; the claims cover actual compositions of the nifedipine drug, methods of making the drug, and methods of treatment using the drug. Each claim specifies a SSA range for the nifedipine crystal used. Claim 1, which Bayer asserts against Elan, is representative of the composition

Page 1246

claims and recites the broadest SSA range:

1. A solid pharmaceutical composition comprising as the active ingredient an effective amount of nifedipine crystals with a specific surface area of 1.0 to 4 m2/g, in admixture with a solid diluent, to result in a sustained release of nifedipine.

'446 patent, col. 5, ll. 30-34.

C. Elan's ANDA

Elan submitted an ANDA to the FDA on April 30, 1997, seeking approval for a product that is bioequivalent to Bayer's ADALAT CC product. Elan's ANDA covers a once-daily formulation of nifedipine--an extended release tablet dosage form containing 30 mg of nifedipine. With its ANDA, Elan filed a Certificate of Quality and Analysis ("COA"). The COA related to an analysis performed by Freiberger NE-Metall GmbH ("FNM"), an independent laboratory, on April 17, 1996 with respect to the micronized--finely ground--nifedipine provided to Elan by its nifedipine supplier, Arzneimittelwerk Dresden GmbH ("AWD"). According to the COA, the measured SSA of the micronized AWD nifedipine crystals was 6.15 m2/g. The tablets made from these micronized nifedipine crystals and tested for the ANDA process are referred to by the parties as the "biobatch." Elan also filed with its ANDA a Paragraph IV certification, in which it stated that its nifedipine composition did not infringe the '446 patent or Bayer's United States Patent No. 4,892,741 (the "'741 patent"). On July 8, 1997, Elan sent Bayer, as required by 21 U.S.C. § 505(j)(2)(B)(ii), notice of its ANDA and its Paragraph IV certification, noting that the SSA of its nifedipine was outside any of the '446 patent's claimed SSA ranges.

On March 18, 1998, Elan amended its ANDA by stating that it had revised the specification for its composition so that the composition only covered nifedipine crystals of a SSA of 5 m2/g or greater. On October 23, 1998, in response to the FDA's request for Elan to define its method of testing and its testing commitment to ensure the nifedipine's SSA, Elan stated that it intended to measure the SSA of its nifedipine no more than five business days before tablet manufacture and that it would discard any nifedipine having a SSA of less than 5 m2/g.

D. District Court Proceedings

After receiving...

To continue reading